MAUDE Adverse Event Report: ARTHREX INC. BIO-COMPSITE CORKSCREW FT 4.5X 14MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number AR-1927BCF-45

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record revealed nothing relevant to this event.The device was requested and is expected for evaluation but has not yet been received therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.

Event Description

It was reported that during a case, as the surgeon was inserting the bio-composite corkscrew, the anchor broke about halfway into the bone.The surgeon was satisfied with the fixation and the case was completed without further complication.Follow-up investigation: it was reported that during a remplissage case, the surgeon was inserting the bio-composite corkscrew when the anchor broke with approximately 7 mm seated into the bone.Approximately 7 mm of the anchor seated into the bone and the rest of the anchor broke off and was removed from the patient.Sales representative was present for the case.

• Brand Name: BIO-COMPSITE CORKSCREW FT 4.5X 14MM
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath, adverrse events ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337013
• MDR Report Key: 6798302
• MDR Text Key: 82840408
• Report Number: 1220246-2017-00300
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867023376
• UDI-Public: 00888867023376
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K082810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2017
• Device Catalogue Number: AR-1927BCF-45
• Device Lot Number: 10079139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2017
• Initial Date FDA Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other